Three medical device directives are part of the New Approach: MDD 93/42/EEC; Active Implantable Medical Devices Directive AIMDD 90/385/EEC; and In Vitro Diagnostic Directives IVDD 98/79/EC. This white paper covers an overview of CE Marking, a review of EU directives, Regulatory documentation and Notified Body involvement, and the Declaration of Conformity, as well as an FAQ about CE Marking.
Labeling, Instructions for Use (IFU) and translation may seem like minor issues compared to larger registration efforts for medical device manufacturers who wish to access the European Union market, but the accuracy of the information supplied with your medical device is essential to avoid costly mistakes, market entry delays and the ire of regulators. This article will address key issues regarding the requirements for labeling of medical devices falling under the European Medical Devices Directive (MDD 93/42/EEC), IFU and translation, as well as the current status of European standards on the use of graphical symbols in medical device labeling.
Selecting a Notified Body is a crucial step for obtaining CE Marking and registering your medical device for sale in the European Union. This article will cover key considerations for medical device manufacturers during their Notified Body searches, as well as what to do if and when it comes time to find a new Notified Body partner.
Obtaining CE Mark certification is the most crucial step for medical device companies seeking to commercialize their products in the European Union. But in the rush to comply with European regulatory requirements and get all required documentation in order, some firms overlook the fact that their devices, no matter how innovative or beneficial, cannot sell themselves. In this white paper you will learn about how to evaluate European distributors, issues regarding contracts, managing distributor payments, documentation and shipping requirements, plus much more…
Highly anticipated reforms to the EU medical device regulations have been announced in recent weeks that will have major ramifications for medical and in vitro diagnostic device manufacturers active in Europe—as well as for their authorized representatives, Notified Bodies, distributors and importers. Once implemented, these proposed reforms will be the most significant changes to the EU medical device market in years. They expand the regulatory scope, establish more substantial definitions and responsibilities, and add more safety and performance requirements. Specific changes that will impact manufacturers include…
Manufacturers are often reluctant to file vigilance reports with Competent Authorities because doing so may be construed as an implicit admission of guilt. In fact, the opposite is true; filing a vigilance report will not result in regulators automatically concluding that the medical device in question caused or contributed to an incident. Still, vigilance reporting remains at a level where under-reporting is assumed to still be widespread. It is a confusing subject for many manufacturers. In this whitepaper, we’ll discuss which types of incidents must be reported to Competent Authorities and which do not.
The decision whether to conduct a clinical investigation is a difficult and major one. Clinical Investigations or studies are easily the single most expensive and time–consuming endeavors undertaken by a medical device manufacturer on the pathway to CE Marking. Misunderstanding with Notified Bodies (NB) or errors in the planning, conduct, evaluation or reporting of clinical studies are currently the main causes for serious delay of market access in Europe.
This white paper walks you through the process getting a medical device cleared for sale by the US FDA, how to determine the classification of your device, finding appropriate predicate devices already cleared by the FDA, the FDA quality system requirements, and online registration requirements. Also discussed are the six most common mistakes that delay a 510(k) submission.
The FDA implemented the Unique Device Identification (UDI) regulation in 2013. A regulation (as opposed to a guidance document) requires mandatory compliance. This white paper will discuss the basics of the regulation, some key points that must be considered, and the preparation a company can undertake to help ensure proper implementation of a UDI system. Topics include: who needs to comply, deadlines for compliance, and how the program works.
Whole living organ transplants are not the only time medicine uses human or animal tissue. There are medical products which contain or are composed of animal and donated human cells and tissues, utilized for a wide range of medical purposes. Determining how these products are regulated by the government can often be daunting and difficult. This article will focus solely on those products containing human tissues and/or cells. These are commonly referred to as HCT/Ps (Human Cells, Tissues, and cellular and tissue-based Products).
Included in the US Patient Protection and Affordable Care Act (PPACA) is a 2.3% excise tax applicable to manufacturers and importers of taxable medical devices that are sold or imported in/to the United States. This white paper provides a detailed overview of the tax, to whom it applies, and how payments need to be made to the Internal Revenue Service. Also included are examples of how to calculate the tax, and explanations of when payments need to be made.
Medical device manufacturers are well aware of the benefits cellular technology can bring to their products. A cellular link, for example, can send patient data off-site to enable remote monitoring. Although cellular technology adds exciting new possibilities for healthcare, it also adds regulatory burdens. In this white paper you learn about the steps a company should consider before marketing their wireless medical device in international markets.